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Oncotype DX(R) AR-V7 Nucleus Detect(TM) Test - Favorable Draft LCD

Epic Sciences and Genomic Health Announce Favorable Draft Local Coverage Determination (LCD) on Medicare Coverage for Use of the Oncotype DX(R) AR-V7 Nucleus Detect(TM) Test in Patients with Metastatic Castration-Resistant Prostate Cancer.

Medicare Draft Coverage Supports Clinical Utility of the Oncotype DX AR-V7 Nucleus Detect Test, Providing 25,000 Medicare Patients with Coverage Once LCD Is Finalized Epic Sciences, Inc. (Epic) and Genomic Health, Inc. (Nasdaq: GHDX) announced today that Palmetto GBA, a Medicare Administrative Contractor (MAC) that assesses molecular diagnostic technologies, has issued a draft local coverage determination (LCD) for the Oncotype DX® AR-V7 Nucleus Detect™ test. The draft LCD recommends Medicare coverage for use of the test throughout the United States to help determine which patients with metastatic castration-resistant prostate cancer (mCRPC) may benefit from androgen receptor signaling inhibitor (ARSi) therapy and which may benefit from chemotherapy. The Oncotype DX AR-V7 Nucleus Detect test is a circulating tumor cell (CTC)-based, liquid biopsy test that is commercially available in the United States through Epic's partnership with Genomic Health.  

"The Oncotype DX AR-V7 Nucleus Detect test is the first and only predictive and prognostic test in prostate cancer that can identify which patients will no longer benefit from ARSi therapies, such as enzalutamide and abiraterone, and need to switch to chemotherapy or start another type of therapy in order to extend life," said Murali Prahalad, Ph.D., president and CEO of Epic Sciences. "The rapid issuance of the draft LCD recommending Medicare coverage highlights the clinical utility and value of this new test in prolonging survival for men with metastatic castration-resistant prostate cancer."